Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.

FDA DeterminedCause 2

PRODUCTION CONTROLS: Process Control

Action

Hospira, Inc. issued an "Important Administration Set Information" letter dated November 24, 2009 to their direct accounts, informing them of the affected product. Consignees were instructed to return the defective product to the firm.
For further information, contact Hospira Medical Communications at 1-800-615-0187.